Enemata administering device

ABSTRACT

An enemata administering device is disclosed which includes a hollow stem with an exit port at one end, fluid inlet at the other end, and expandable cylindrical sleeve of substantially constant diameter sealed at its ends onto the exterior surface of the stem near the exit ports and a conduit for inflating the sleeve. The ends of the sleeve are spaced apart less than the length of the sleeve and a reentrant section at an end of the sleeve is provided to take up the excess sleeve material.

United States Patent 1 Greene 1 1 ENEMATA ADMINISTERING DEVICE [75] Inventor: Franklin R. Greene, Flushing, NY. [73] Assignee: E-Z-EM Company Inc., Westbury,

[22] Filed: Mar. 30, 1973 [21] Appl. No.: 346,614

52 us. Cl. 128/246; 128/349 B 51 Int. Cl A61m 3/00 [58] Field of Search 128/246, 245, 349, 351, 128/348, 2 R

[56] References Cited UNITED STATES PATENTS 2,792,837 5/1967 Kardos 128/349 B 2,892,458 6/1959 Auzin.... 128/349 B 2,930,377 3/1960 C0wley.. 128/349 B 2,936,760 5/1960 Gants 128/349 B 3,053,257 9/1962 Birtwell 129/349 B 1 June 17, 1975 3,459,175 8/1969 Miller 3,633,586 l/1972 Sheridan 128/349 B 3,634,924 1/1972 Blake et a1. 128/349 B Primary ExaminerRichard A. Gaudet Assistant Examiner.l. Yasko Attorney, Agent, or FirmRyder, McAulay, Fields, Fisher & Goldstein V ENEMATA ADMINISTERING DEVICE BACKGROUND OF THE INVENTION This invention relates to devices for giving enemata and, more particularly, to a device which precludes accidental expulsion of an enemata apparatus and the enema fluid.

Enamata devices are used to permit the controlled rectal injection of a fluid for many purposes including purgation, medicinal and diagonistic such as through the use of X-rays. As one example, frequently an enema is given to place a barium solution in the colon during X-ray examination.

Many enemata devices presently exist and are being used for these purposes. It is well known to place an inflatable baloon like sleeve adjacent the distal end (clyster tip) of the apparatus in order to control and preclude premature expulsion of the apparatus itself and the injected fluid. In order to limit the extent of penetration into the anal canal by the enemata apparatus and still obtain sufficient inflation of the inflatable sleeve to accomplish its intended purpose, sleeves of the type having an accordian structure are commonly used. Such a sleeve is illustrated in U.S. Pat. No. 3,459,175.

In order to insert an enemata device using the accordian like sleeve it is necessary for the administrator to wrap or fold the sleeve about the hollow tube of the enemata apparatus to facilitate insertion of the apparatus into the anal canal. After the apparatus is inserted and the sleeve inflated, the administrator pulls back on the apparatus in order to be sure that the inflated sleeve abuts the anal sphincter mucles in order to obturate the anal canal. It is also standard practice for a conduit employed to inflate the sleeve to be located on the exterior of the hollow tube and, consequently, also be inserted through the anal canal. The bulk of the folded accordian sleeve and the flexible conduit has been found to be discomforting to the patient. Obviously, it is preferred to reduce the size of the enemata apparatus as much as possible without sacrificing the effectiveness of the apparatus, including the effectiveness of the expulsion control means.

It is also preferable to have a disposable enemata apparatus. However, in order for the device to be disposable it is essential that it be produced at minimal expense thereby requiring minimal material and labor in its production.

Accordingly, it is an objective of this invention to provide an improved enemata administering device which can be manufactured easily and inexpensively, which has less bulk than existing devices and which can be inserted into the patient with less patient discomfort than existing devices.

It is a further objective of this invention to provide an improved enemata administering device which may be inserted and placed in operative position by the administrator easily and with minimal manipulation and which may be inserted into the anal canal a minimal distance.

BRIEF DESCRIPTION OF THE INVENTION Briefly described, this invention in one form comprises an improved enemata administering device formed of a hollow stem having exit ports at the clyster tip or distal end thereof and a fluid inlet at the proximal end of the stem. A cylindrical, expandable resilient sleeve is mounted on the exterior of the stem immediately adjacent the clyster tip. The sleeve is formed with one end thereof having a reentrant section. Only a portion of the reentrant section, namely a small section immediately adjacent the inner most end of the reentrant section is hermetically sealed to the exterior surface of the stem. The other end of the sleeve also is hermetically sealed to the stem.

A conduit is provided to permit controlled inflation of the sleeve. The conduit is located inside the hollow stem and projects through an aperture in the stem so that it communicates with the interior of the sleeve. The other end of the conduit projects through an aperture at the proximal end of the stern so that it may be connected to a source of fluid, such as an air syringe. Application of pressure to the interior surface of the sleeve causes the sleeve to be inflated thereby providing the desired expulsion control structure.

BRIEF DESCRIPTION OF THE DRAWINGS The above objectives and attendant advantages may be better understood from the detailed description below together with the attached drawings in which:

FIG. 1 is a perspective illustration of an enemata administering device formed in accordance with one embodiment of this invention.

FIG. 2 is a sectional view taken along line 2-2 of FIG. 1.

FIG. 3 is a sectional view of a portion of the device of FIG. 1 showing a sleeve expanded.

FIG. 4 is a sectional view of an enemata administering device formed in accordance with a second embodiment of this invention.

DETAILED DESCRIPTION OF THE INVENTION In FIGS. 1-3 there is illustrated an improved enemata administering device 10 formed in accordance with a first embodiment of this invention. The device includes a smooth, flexible, plastic tubular enema stem 12 having a distal end clyster tip portion 14 of conventional shape, such as a tapered bulbular shape. The clyster tip 14 is provided with a primary exit orifice 16 at the extreme distal end thereof and a plurality of secondary exit ports 18 through the sides thereof. The remainder of the enema stem 12 is cylindrical and terminates at the proximal end 20 into which may be inserted or, alternatively, onto which may be formed a bayonette type connector 22 adapted to receive a flexible tube 24 from a fluid supply such as an enema fluid container (not shown). The enema stem 12 is formed of a suitable plastic material such as polyvinylchloride which may be easily molded or extruded into the desired shape.

An expandable resilient sleeve 30, preferably made of latex, is mounted on the exterior of the enema stem 12. The sleeve 30, prior to mounting on the stem 12, is of cylindrical shape having a thin single wall. When mounted on the stem 12 both ends 32, 36 of the sleeve 30 are hermetically sealed to the stem at a distance spaced from each other less than the total length of the sleeve. For example, with a 2 inch long sleeve 30 about a one-sixteenth inch section at the extreme ends 32, 36 of the sleeve are sealed to the stern, spaced apart 1% inches. The sleeve 30 is then folded over at one end, namely the end thereof remote from the clyster tip 14 to form a reentrant section 34. As a result, only a portion (about one-sixteenth inch) of the reentrant section 34 (which is about one-fourth inch long) is hermetically sealed to the stem 12, that portion being the end 32 of the sleeve which also forms the innermost end of the reentrant section 34. Thus, in this example, about three-sixteenths inch of the reentrant section 34 is available to be inflated with the rest of the sleeve 30 to increase the ultimate diameter of the inflated sleeve 30.

An aperture 38 is provided through the stem 12 to receive a flexible conduit 40 which is located within the interior of the stem 12. The front end of the conduit 40, which also may be made of polyvinylchloride, is sealed to the conduit wall defining the aperture 38 so that it communicates with the interior of the sleeve 30 while the back end of the conduit 40 passes through a second aperture 42 formed near the proximal end of the stem 12 and is adapted to removably receive a fluid source such as an air syringe 44.

In operation, the clyster tip 14 of the stem 12 is inserted into the patients bowel through the anal canal a distance sufficient to clear the reentrant section 34 of the inflatable sleeve beyond the anal sphincter muscles. Because the reentrant portion 34 of the sleeve 30 is at the back end of the sleeve 30, the forward end or end which is first inserted through the anal canal is only a single layer thick and lies flat and smooth upon the enema stem 12 thereby minimizing the risk of the forward end 36 of the sleeve 30 forming an obstructive discomforting abutment or tending to be pulled free from the stem 12 during insertion of the stem through the anal canal. After the enemata administering device 10 is inserted the sleeve 30 is inflated by pumping air through the conduit 40 into the interior of the sleeve 30. As the sleeve 30 expands the reentrant section 34 unfolds to enlarge the ultimate diameter of the inflated sleeve 30 beyond what would be the case with a sleeve having the same length but without the reentrant section. Of course, the reentrant portion will only lift off the stem 12 up to the point 32 where the sleeve 30 is hermetically sealed to the stem 12 (see FIG. 3).

A conventional clamp 46 may then be closed upon the conduit 40 to retain the air within the expanded sleeve 30. The inflated ballooned sleeve 30 now serves to block or preclude the enemata administering device 10 from being accidentally or prematurely expelled from the bowel. Furthermore, it also precludes flow of fluid from the bowel. The enemata administering device 10 is now ready to be used for the purpose for which it is inserted. A fluid, such as a barium sulphate suspension, may now be pumped into the bowel for X-ray observance. The barium suspension, or other suitable fluid, is pumped through the tube 24 and the hollow stem 12 out through the exit ports 16, 18 into the bowel.

Upon completion of the administration of the enema, the air is removed from the inflated sleeve 30 by opening the clamp 46. Because of the direction of the pressure applied by the anal sphincter muscles on the inflated balloon sleeve 30, as the sleeve deflates it tends to ride up toward the clyster tip 14 forming a reentrant portion at the front end of the sleeve thereby forming a single layer, smooth back end 32 of the sleeve 30. The back end 32 is the end whch is first exposed to the anal canal as the enemata administering device 10 is withdrawn through the anal canal thereby again minimizing discomforting abutment of the sleeve during removal of the device 10 through the anal canal.

FIG. 4 illustrates an enemata administering device 50 formed in accordance with a second embodiment of this invention. In addition to the sleeve 30 in the form described above in the first embodiment and illustrated in FIGS. ll3, an additional inflatable sleeve 52 is mounted on the stem 12 and spaced from the back end of the sleeve 30. The second or additional sleeve 52 may have the form of the first sleeve 30 or, alternatively, in a preferred form of this invention, the second sleeve 52 is provided with the conventional accordian shaped form wherein the conduit 54 used for inflating the second sleeve 52 is mounted on the exterior of the stem 12 and communicated with the interior of the sleeve 52.

The purpose for the second sleeve 52 is that once the enemata administering device 50 is inserted through the anal canal into the bowel, the first sleeve 30 is located inside the bowel while the second sleeve 52 is located outside the patient and, when inflated, tends to pull the internal inflated sleeve 30 against the anus to help sea] the anal canal. Because the second sleeve 52 remains outside the patient, there is no need to have the conduit 54 which is used for inflating the sleeve 52 located internally within the hollow stem 12 since the conduit will not be inserted into the patient and therefore will provide no discomfort to the patient.

It can be seen that the enemata administering device of this invention provides a device which is easy and inexpensive to manufacture since it requires less material than that previously used in the accordian shaped inflatable sleeve. More importantly, there is less bulk located on the exterior surface of the enema stem thereby making it easier and less discomforting to insert this improved enemata administering device into the patient. There is no need for the administrator to fold and hold the inflatable sleeve during insertion of the device 10 into the patient as was formerly done with the accordian type inflatable sleeve.

When using the known fluted or similar inflatable balloon, the standard procedure is to insert the device a distance great enough to clear the folded back balloon, inflate and then pull back to seat the inflated balloon against the sphincter. This procedure is simplified and made less uncomfortable through the use of this invention. Because of the simple, smooth fold at the reentrant portion 34, the balloon 30 when inflated will pull the reentrant portion free of the sphincter. Thus the device 10 or 50 can be inserted no further than necessary to seat the inflated balloon 30.

By locating the conduit 40 for inflating the sleeve within the stem 12 there is a further reduction in the bulk inserted through the anal canal and, concommitently, a further reduction in discomfort.

By virtue of the construction of the device of this invention, the reentrant portion of the sleeve 30 is always on the end of the sleeve opposite to the portion of the device first moving through the anal canal. Therefore, there is less chance of the sleeve abutting against the anal canal and less discomfort to the patient.

What is claimed is:

1. An enemata administering device comprising: a hollow stem having exit ports at a distal end thereof, an inlet at the proximal end thereof for receiving a fluid, a smooth expandable resilient cylindircal sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stern near said distal end of said stem, said sleeve being hermetically sealed to said stem at both ends of said sleeve, said sleeve having an unsealed section between said sealed ends, said ends of said sleeve being sealed to said stem a distance apart along said stem substantially less than the unsealed length of said sleeve when said sleeve is deflated, only the proximal end of said sleeve having a reentrant section to take up the resultant extra length of sleeve material, only a portion of said reentrant section being sealed to said stem, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve conforming to said stem when deflated, and means for inflating said sleeve.

2. The enemata administering device of claim 1 wherein said stem has an aperture therethrough communicating with the interior surface of said sleeve and wherein said means for inflating comprises a conduit located inside said stem in communication with the interior of said sleeve through said aperture.

3. An enemata administering device comprising: a hollow stem having a forward end adapted to be inserted through the anal canal into a patients bowel, said forward end having exit ports therethrough, the back end of said stem adapted for fluid communication with a fluid source, a smooth expandable, resilient, single wall cylindrical sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stem near said forward end at a position adapted to being located within the patients bowel when said device is in use, said sleeve being hermetically sealed to said stem at both ends of said sleeve, said sleeve having an unsealed section between said sealed ends, said ends of said sleeve being sealed to said stem a distance apart along said stem substantially less than the unsealed length of said sleeve when said sleeve is deflated, only the proximal end of said sleeve having a reentrant section to take up the resultant extra length of sleeve material, only a portion of said reentrant section being sealed to said stem, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve conforming to said stern when deflated, a conduit within said stem communicating at one end with the interior of said sleeve and at the other end with a second fluid source to permit selective inflation and deflation of said sleeve.

4. An enemata administering device comprising a hollow stem having a forward end adapted to be inserted through the anal canal into a patients bowel, said forward end having exit ports therethrough, the back end of said stem adapted for fluid communication with a fluid source, an expandable, resilient, single wall cylindrical sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stem near said forward end at a position adapted to being located within the patients bowel when said device is in use, both ends of said sleeve being hermetically sealed to said stem a distance apart along said stem substantially less than the length of said sleeve when said sleeve is deflated, said sleeve having a reentrant section adjacent to one end of said sleeve to take up the resultant excess sleeve material, only a portion of said reentrant section being sealed to said stern, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve lying flat on said stem when deflated, a conduit within said stem communicating at one end with the interior of said sleeve and at the other end with a second fluid source to permit selective inflation and deflation of said sleeve, said reentrant section of said sleeve being only at the end of said sleeve furthest from the forward end of said stem during insertion of the device into the patients anal canal and at the end of said stem closest to the forward end of said stem during retraction of the device from the patients anal canal. 

1. An enemata administering device comprising: a hollow stem having exit ports at a distal end thereof, an inlet at the proximal end thereof for receiving a fluid, a smooth expandable resilient cylindircal sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stem near said distal end of said stem, said sleeve being hermetically sealed to said stem at both ends of said sleeve, said sleeve having an unsealed section between said sealed ends, said ends of said sleeve being sealed to said stem a distance apart along said stem substantially less than the unsealed length of said sleeve when said sleeve is deflated, only the proximal end of said sleeve having a reentrant section to take up the resultant extra length of sleeve material, only a portion of said reentrant section being sealed to said stem, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve conforming to said stem when deflated, and means for inflating said sleeve.
 2. The enemata administering device of claim 1 wherein said stem has an aperture therethrough communicating with the interior surface of said sleeve and wherein said means for inflating comprises a conduit located inside said stem in communication with the interior of said sleeve through said aperture.
 3. An enemata administering device comprising: a hollow stem having a forward end adapted to be inserted through the anal canal into a patient''s bowel, said forward end having exit ports therethrough, the back end of said stem adapted for fluid communication with a Fluid source, a smooth expandable, resilient, single wall cylindrical sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stem near said forward end at a position adapted to being located within the patient''s bowel when said device is in use, said sleeve being hermetically sealed to said stem at both ends of said sleeve, said sleeve having an unsealed section between said sealed ends, said ends of said sleeve being sealed to said stem a distance apart along said stem substantially less than the unsealed length of said sleeve when said sleeve is deflated, only the proximal end of said sleeve having a reentrant section to take up the resultant extra length of sleeve material, only a portion of said reentrant section being sealed to said stem, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve conforming to said stem when deflated, a conduit within said stem communicating at one end with the interior of said sleeve and at the other end with a second fluid source to permit selective inflation and deflation of said sleeve.
 4. An enemata administering device comprising a hollow stem having a forward end adapted to be inserted through the anal canal into a patient''s bowel, said forward end having exit ports therethrough, the back end of said stem adapted for fluid communication with a fluid source, an expandable, resilient, single wall cylindrical sleeve of substantially constant diameter and substantially constant wall thickness mounted on the exterior surface of said stem near said forward end at a position adapted to being located within the patient''s bowel when said device is in use, both ends of said sleeve being hermetically sealed to said stem a distance apart along said stem substantially less than the length of said sleeve when said sleeve is deflated, said sleeve having a reentrant section adjacent to one end of said sleeve to take up the resultant excess sleeve material, only a portion of said reentrant section being sealed to said stem, a substantial portion of said reentrant section being free to expand away from said stem, said sleeve lying flat on said stem when deflated, a conduit within said stem communicating at one end with the interior of said sleeve and at the other end with a second fluid source to permit selective inflation and deflation of said sleeve, said reentrant section of said sleeve being only at the end of said sleeve furthest from the forward end of said stem during insertion of the device into the patient''s anal canal and at the end of said stem closest to the forward end of said stem during retraction of the device from the patient''s anal canal. 